InsomniaNASCNCT06694441
Noradrenergic Dysregulation, Sleep and Cognition in Older Adults With Insomnia
A study testing Light Exposure in people with Insomnia, run by Northwestern University at 1 site in United States.
Trial summary
This study investigates the relationship between the noradrenergic (NA) system, sleep quality, and cognitive function in older adults with insomnia - a population at elevated risk for Alzheimer's disease-related dementias (ADRD) - compared to age and sex matched controls with normal sleep. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Light Exposure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2024to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 55 years;
- Independent in activities of daily living and without clinically significant cognitive impairment as determined by a mini-mental status examination (MMSE) score ≥ 26;
- Due to the effect of reproductive hormones on autonomic regulation, sleep and cognition, women will be postmenopausal;
- time spent in bed not greater than 8.5 hours;
- Sedentary, defined as participation in exercise of moderate intensity for less than 30 minutes per day and less than two times per week on a regular basis.
- average daily light exposure indicative of indoor environments (from questionnaire).
Show all 16Show fewer
- Meet criteria for chronic insomnia disorder according to the International Classification of Sleep Disorders (3rd Ed.);
- Subjective sleep efficiency less than 85% and/or awakening earlier than desired if before 6 AM for ≥3 nights/week in the previous 4 weeks;
- Subjective WASO (sWASO) ≥ 60 minutes for ≥3 nights/week in previous 4 weeks. sWASO will include time spent awake after sleep onset before final awakening + time spent awake in bed attempting to sleep after the final awakening;
- global PSQI score greater than 5;
- average daily light exposure indicative of indoor environments (from questionnaire).
- No history of chronic or short-term insomnia disorder according to the International Classification of Sleep Disorders (3rd Ed.);
- Subjective sleep efficiency greater than 85%;
- Subjective mean total sleep time of 6.5 hours to 8 hours;
- Habitual bedtime of 9PM-midnight;
- PSQI score ≤ 5. Participants in the control group will be matched with the insomnia group on sex and age (±3 years).
Who cannot join
- Sleep disorders other than insomnia (restless legs syndrome, parasomnias, REM behavior disorder, circadian rhythm sleep-wake disorder, sleep apnea by STOP questionnaire and apnea hypopnea index (AHI) ≥ 15 by home sleep apnea test;
- habitual bedtime before 9pm or morning awakening before 5am;
- History of neurological disorders;
- History of psychiatric disorders;
- A Beck depression inventory ((BDI-II) score greater than 19);
- Unstable or serious medical conditions;
Show all 17Show fewer
- Prediabetes and diabetes (HbA1C ≥ 5.7)
- Current, or use within the past month, of psychoactive, hypnotic, stimulant or analgesic medications (except occasionally);
- Use of medications that interfere with NA system activity including B-blockers, selective serotonin and norepinephrine reuptake inhibitors (SNRIs) and selective norepinephrine-dopamine reuptake inhibitors (NDRIs);
- Hormone replacement therapy;
- Use of medications that affects pupil diameter and responses to light (i.e. antihistamines, anticholinergics, benzodiazepines, narcotics for pain;
- History of visual abnormalities that may interfere with pupillary responses to light exposure such as significant cataracts, narrow-angle glaucoma or blindness;
- History of heart conditions (i.e. arrhythmia, coronary artery disease, angina, heart failure);
- Shift work or other types of self-imposed irregular sleep schedules;
- BMI > 35 kg/m2;
- History of habitual smoking (6 or more cigarettes/week) or caffeine consumption > 400 mg/day.
- 17.Use of weight-loss medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University Feinberg School of Medicine, Center for Circadian and Sleep Medicine
Chicago, Illinois, 60611
Marguerite McGuire, 844-707-5337 ext. 844-707-5337, marguerite.mcguire@northwestern.edu
Daniela Grimaldi, MD, PhD, 844-707-5337, daniela.grimaldi@northwestern.edu
About this study
This study investigates the relationship between the noradrenergic (NA) system, sleep quality, and cognitive function in older adults with insomnia - a population at elevated risk for Alzheimer's disease-related dementias (ADRD) - compared to age and sex matched controls with normal sleep. The study characterizes NA function through multiple approaches: measuring 24-hour plasma levels of norepinephrine (NE) and its brain metabolite 3-methoxy-4-hydroxyphenylglycol (MHPG); evaluating central NA system response using the clonidine suppression test (a presynaptic α2 adrenoreceptor agonist that reduces locus coeruleus NA activity; and employing pupillometry as a non-invasive marker of autonomic function. To explore NA function's mechanistic role in insomnia, the study uses an intervention with bright light exposure to enhance daytime NA activity, with the goal of improving both sleep quality and cognitive performance.
- Conditions
- Insomnia
- Being tested
- Light Exposure, Placebo
- Keywords
- Insomnia, Older Adults, Noradrenergic dysregulation, sleep, cognition, cognitive function
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light ExposureOther
The intervention in this study will involve 28 (+10) days of daily exposure to bright light (BL) for two 60-minute sessions (morning and afternoon). For the intervention, we will use Re-Timer® light glasses emitting light with an intensity of 230μW/cm2 (~500lux) with a green blue 500nm dominant wavelength (between 480-520nm). Light with these characteristics has been shown effective in suppressing melatonin levels supporting their potential to exert effects on other biological non-visual functions associated with exposure to light relevant for this study. Throughout the intervention, participants will keep a diary to monitor daily use of the glasses. Participants will have weekly phone calls with the research team to encourage compliance and monitor potential side effects.
PlaceboOther
Participants randomized to the control group will wear for two 60-minute sessions (morning and afternoon) customized dim-red light (RL) control Re-Timer® light glasses (wavelength peak at 632nm, light intensity < 3 lux).
| Study group | Role | What they receive |
|---|---|---|
| Intervention on Subjects with Insomnia | Experimental | The intervention in this study will involve 28 (+10) days of daily exposure to bright light (BL) for two 60-minute sessions (morning and afternoon).
For the intervention, we will use Re-Timer® light glasses emitting light with an intensity of 230μW/cm2 (~500lux) with a green blue 500nm dominant wavelength (between 480-520nm). Light with these characteristics has been shown effective in suppressing melatonin levels supporting their potential to exert effects on other biological non-visual functions associated with exposure to light relevant for this study.
Throughout the intervention, participants will keep a diary to monitor daily use of the glasses. Participants will have weekly phone calls with the research team to encourage compliance and monitor potential side effects. Receives: Other: Light Exposure |
| Dim Red Light | Active comparator | Participants randomized to the control group will wear for two 60-minute sessions (morning and afternoon) customized dim-red light (RL) control Re-Timer® light glasses (wavelength peak at 632nm, light intensity < 3 lux). Participants will be instructed to wear the light glasses in habitual indoor environments, without engaging in strenuous activities. Throughout the intervention, participants will keep a diary to monitor daily use of the glasses. Participants will have weekly phone calls with the research team to encourage compliance and monitor potential side effects. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
24h plasma norepinephrine
24-h plasma norepinephrine (pg/mL) collected every two hours
Measured: Enrollment to the end of treatment at 10 weeks.
Clonidine suppression test
Plasma norepinephrine levels (pg/mL) and 3- plasma 3-methoxy-4-hydroxyphenylglycol (MHPG, ng/mL) levels in response to clonidine suppression test. Collected at baseline and every 30 minutes for 2 hours after clonidine ingestion.
Measured: Enrollment
Wake after sleep onset (WASO)
Duration in minutes obtained from polysomnography and actigraphy
Measured: Enrollment to the end of treatment at 10 weeks.
Slow oscillatory activity during sleep
SO activity (0.5 - 1Hz) is measured from EEG during in laboratory stay
Measured: Enrollment to the end of treatment at 10 weeks.
Pittsburg Sleep Quality Index
Self administered questionnaire to evaluate subjective sleep quality
Measured: Enrollment to the end of treatment at 10 weeks.
NIH tool box
Cognitive battery to assess executive functions, attention, episodic and working memory
Measured: Enrollment to the end of treatment at 10 weeks.
Secondary outcomes (9)
24-h plasma 3-methoxy-4-hydroxyphenylglycol (MHPG)
MHPG (ng/mL) is the main metabolite of Norepinephrine from the brain measured in plasma.
Measured: Enrollment to the end of treatment at 10 weeks.
24-h plasma cortisol levels
24-h plasma cortisol levels (nmol/L) collected every two hours as a measure of autonomic activation
Measured: Enrollment to the end of treatment at 10 weeks.
24h plasma melatonin
24-h plasma melatonin (pg/mL) collected every two hour as a circadian measure
Measured: Enrollment to the end of treatment at 10 weeks.
Pupillometry
Pupil size (measure of autonomic activation)
Measured: Enrollment to the end of treatment at 10 weeks.
Psychomotor Vigilance Test
To assess reaction time (ms)
Measured: Enrollment to the end of treatment at 10 weeks.
Wake EEG
EEG power in alpha band during wake to measure vigilance levels
Measured: Enrollment to the end of treatment at 10 weeks.
Heart Rate and Heart Rate Variability
HR (bpm) and measures of HRV variability (high frequency (HF) component and low frequency to high frequency ratio LF/HF to assess autonomic function and sympatho-vagal balnce
Measured: Enrollment to the end of treatment at 10 weeks.
Insomnia Severity Index
Questionnaire to measure insomnia severity
Measured: Enrollment to the end of treatment at 10 weeks.
Visual Analogue Scale
Scale to measure global vigor ( score 0 to 100) and global alertness (0 to 100). Higher scores indicate greater levels of both vigor and positive affect.
Measured: Enrollment to the end of treatment at 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start30 Sep 2024
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Daniela Grimaldi, Northwestern University
- Investigators
- Daniela Grimaldi, MD, PhD, Principal investigator, Northwestern UniversityPhyllis C Zee, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694441
- Sponsor's protocol ID
- STU00219832
- Other IDs
- R01AG081520-01A1, 4RF1AG081520-02
- Acronym
- NASC
- Status last verified
- Mar 2026
- First submitted
- 13 Nov 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van Egroo M, Koshmanova E, Vandewalle G, Jacobs HIL. Importance of the locus coeruleus-norepinephrine system in sleep-wake regulation: Implications for aging and Alzheimer's disease. Sleep Med Rev. 2022 Apr;62:101592. doi: 10.1016/j.smrv.2022.101592. Epub 2022 Jan 21.
PubMed 35124476Mann DM. The locus coeruleus and its possible role in ageing and degenerative disease of the human central nervous system. Mech Ageing Dev. 1983 Sep;23(1):73-94. doi: 10.1016/0047-6374(83)90100-8.
PubMed 6228698Cirelli C, Huber R, Gopalakrishnan A, Southard TL, Tononi G. Locus ceruleus control of slow-wave homeostasis. J Neurosci. 2005 May 4;25(18):4503-11. doi: 10.1523/JNEUROSCI.4845-04.2005.
PubMed 15872097McCrae CS, Rowe MA, Tierney CG, Dautovich ND, Definis AL, McNamara JP. Sleep complaints, subjective and objective sleep patterns, health, psychological adjustment, and daytime functioning in community-dwelling older adults. J Gerontol B Psychol Sci Soc Sci. 2005 Jul;60(4):P182-9. doi: 10.1093/geronb/60.4.p182.
PubMed 15980285Lim AS, Kowgier M, Yu L, Buchman AS, Bennett DA. Sleep Fragmentation and the Risk of Incident Alzheimer's Disease and Cognitive Decline in Older Persons. Sleep. 2013 Jul 1;36(7):1027-1032. doi: 10.5665/sleep.2802.
PubMed 23814339Shi L, Chen SJ, Ma MY, Bao YP, Han Y, Wang YM, Shi J, Vitiello MV, Lu L. Sleep disturbances increase the risk of dementia: A systematic review and meta-analysis. Sleep Med Rev. 2018 Aug;40:4-16. doi: 10.1016/j.smrv.2017.06.010. Epub 2017 Jul 6.
PubMed 28890168
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noradrenergic Dysregulation, Sleep and Cognition in Older Adults With Insomnia
- ClinicalTrials.gov ID
- NCT06694441
- Acronym / sponsor ID
- NASC / STU00219832
- Conditions
- Insomnia
- Keywords
- Insomnia, Older Adults, Noradrenergic dysregulation, sleep, cognition, cognitive function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the relationship between the noradrenergic (NA) system, sleep quality, and cognitive function in older adults with insomnia - a population at elevated risk for Alzheimer's disease-related dementias (ADRD) - compared to age and sex matched controls with normal sleep. The study characterizes NA function through multiple approaches: measuring 24-hour plasma levels of norepinephrine (NE) and its brain metabolite 3-methoxy-4-hydroxyphenylglycol (MHPG); evaluating central NA system response using the clonidine suppression test (a presynaptic α2 adrenoreceptor agonist that reduces locus coeruleus NA activity; and employing pupillometry as a non-invasive marker of autonomic function. To explore NA function's mechanistic role in insomnia, the study uses an intervention with bright light exposure to enhance daytime NA activity, with the goal of improving both sleep quality and cognitive performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention on Subjects with Insomnia | Experimental | Other: Light ExposureThe intervention in this study will involve 28 (+10) days of daily exposure to bright light (BL) for two 60-minute sessions (morning and afternoon). For the intervention, we will use Re-Timer® light glasses emitting light with an intensity of 230μW/cm2 (~500lux) with a green blue 500nm dominant wavelength (between 480-520nm). Light with these characteristics has been shown effective in suppressing melatonin levels supporting their potential to exert effects on other biological non-visual functions associated with exposure to light relevant for this study. Throughout the intervention, participants will keep a diary to monitor daily use of the glasses. Participants will have weekly phone calls with the research team to encourage compliance and monitor potential side effects. |
| Dim Red Light | Active comparator | Other: PlaceboParticipants randomized to the control group will wear for two 60-minute sessions (morning and afternoon) customized dim-red light (RL) control Re-Timer® light glasses (wavelength peak at 632nm, light intensity < 3 lux). Participants will be instructed to wear the light glasses in habitual indoor environments, without engaging in strenuous activities. Throughout the intervention, participants will keep a diary to monitor daily use of the glasses. Participants will have weekly phone calls with the research team to encourage compliance and monitor potential side effects. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 55 years;
- Independent in activities of daily living and without clinically significant cognitive impairment as determined by a mini-mental status examination (MMSE) score ≥ 26;
- Due to the effect of reproductive hormones on autonomic regulation, sleep and cognition, women will be postmenopausal;
- time spent in bed not greater than 8.5 hours;
- Sedentary, defined as participation in exercise of moderate intensity for less than 30 minutes per day and less than two times per week on a regular basis.
Key exclusion criteria (17 listed)
- Sleep disorders other than insomnia (restless legs syndrome, parasomnias, REM behavior disorder, circadian rhythm sleep-wake disorder, sleep apnea by STOP questionnaire and apnea hypopnea index (AHI) ≥ 15 by home sleep apnea test;
- habitual bedtime before 9pm or morning awakening before 5am;
- History of neurological disorders;
- History of psychiatric disorders;
- A Beck depression inventory ((BDI-II) score greater than 19);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light ExposureThe intervention in this study will involve 28 (+10) days of daily exposure to bright light (BL) for two 60-minute sessions (morning and afternoon). For the intervention, we will use Re-Timer® light glasses emitting light with an intensity of 230μW/cm2 (~500lux) with a green blue 500nm dominant wavelength (between 480-520nm). Light with these characteristics has been shown effective in suppressing melatonin levels supporting their potential to exert effects on other biological non-visual functions associated with exposure to light relevant for this study. Throughout the intervention, participants will keep a diary to monitor daily use of the glasses. Participants will have weekly phone calls with the research team to encourage compliance and monitor potential side effects. | Other | Intervention on Subjects with Insomnia |
| PlaceboParticipants randomized to the control group will wear for two 60-minute sessions (morning and afternoon) customized dim-red light (RL) control Re-Timer® light glasses (wavelength peak at 632nm, light intensity < 3 lux). | Other | Dim Red Light |
Primary outcome
24h plasma norepinephrine
Time frame: Enrollment to the end of treatment at 10 weeks.
24-h plasma norepinephrine (pg/mL) collected every two hours
Clonidine suppression test
Time frame: Enrollment
Plasma norepinephrine levels (pg/mL) and 3- plasma 3-methoxy-4-hydroxyphenylglycol (MHPG, ng/mL) levels in response to clonidine suppression test. Collected at baseline and every 30 minutes for 2 hours after clonidine ingestion.
Wake after sleep onset (WASO)
Time frame: Enrollment to the end of treatment at 10 weeks.
Duration in minutes obtained from polysomnography and actigraphy
Slow oscillatory activity during sleep
Time frame: Enrollment to the end of treatment at 10 weeks.
SO activity (0.5 - 1Hz) is measured from EEG during in laboratory stay
Pittsburg Sleep Quality Index
Time frame: Enrollment to the end of treatment at 10 weeks.
Self administered questionnaire to evaluate subjective sleep quality
NIH tool box
Time frame: Enrollment to the end of treatment at 10 weeks.
Cognitive battery to assess executive functions, attention, episodic and working memory
9 secondary outcomes
24-h plasma 3-methoxy-4-hydroxyphenylglycol (MHPG)
Time frame: Enrollment to the end of treatment at 10 weeks.
24-h plasma cortisol levels
Time frame: Enrollment to the end of treatment at 10 weeks.
24h plasma melatonin
Time frame: Enrollment to the end of treatment at 10 weeks.
Pupillometry
Time frame: Enrollment to the end of treatment at 10 weeks.
Psychomotor Vigilance Test
Time frame: Enrollment to the end of treatment at 10 weeks.
Wake EEG
Time frame: Enrollment to the end of treatment at 10 weeks.
Heart Rate and Heart Rate Variability
Time frame: Enrollment to the end of treatment at 10 weeks.
Insomnia Severity Index
Time frame: Enrollment to the end of treatment at 10 weeks.
Visual Analogue Scale
Time frame: Enrollment to the end of treatment at 10 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Background: PubMed 35124476Van Egroo M, Koshmanova E, Vandewalle G, Jacobs HIL. Importance of the locus coeruleus-norepinephrine system in sleep-wake regulation: Implications for aging and Alzheimer's disease. Sleep Med Rev. 2022 Apr;62:101592. doi: 10.1016/j.smrv.2022.101592. Epub 2022 Jan 21.
- Background: PubMed 6228698Mann DM. The locus coeruleus and its possible role in ageing and degenerative disease of the human central nervous system. Mech Ageing Dev. 1983 Sep;23(1):73-94. doi: 10.1016/0047-6374(83)90100-8.
- Background: PubMed 15872097Cirelli C, Huber R, Gopalakrishnan A, Southard TL, Tononi G. Locus ceruleus control of slow-wave homeostasis. J Neurosci. 2005 May 4;25(18):4503-11. doi: 10.1523/JNEUROSCI.4845-04.2005.
- Background: PubMed 15980285McCrae CS, Rowe MA, Tierney CG, Dautovich ND, Definis AL, McNamara JP. Sleep complaints, subjective and objective sleep patterns, health, psychological adjustment, and daytime functioning in community-dwelling older adults. J Gerontol B Psychol Sci Soc Sci. 2005 Jul;60(4):P182-9. doi: 10.1093/geronb/60.4.p182.
- Background: PubMed 23814339Lim AS, Kowgier M, Yu L, Buchman AS, Bennett DA. Sleep Fragmentation and the Risk of Incident Alzheimer's Disease and Cognitive Decline in Older Persons. Sleep. 2013 Jul 1;36(7):1027-1032. doi: 10.5665/sleep.2802.
- Background: PubMed 28890168Shi L, Chen SJ, Ma MY, Bao YP, Han Y, Wang YM, Shi J, Vitiello MV, Lu L. Sleep disturbances increase the risk of dementia: A systematic review and meta-analysis. Sleep Med Rev. 2018 Aug;40:4-16. doi: 10.1016/j.smrv.2017.06.010. Epub 2017 Jul 6.
- Center for Circadian and Sleep Medicine WebsiteLink provided by the sponsor.
- REDCap Initial Screening Eligibility FormLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniela Grimaldi, MD, PhD principal investigator
Northwestern University
Phyllis C Zee, MD, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light Exposure in people with Insomnia, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marguerite McGuire (844-707-5337, marguerite.mcguire@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24h plasma norepinephrine (time frame: Enrollment to the end of treatment at 10 weeks.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06694441, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.